NVCN - NVCN STOCK NEWS

Neovasc has appointed Lisa Becker and Sarah Gallagher as Vice Presidents in Regulatory and Clinical Affairs, respectively, strengthening its team as the company pursues development goals in North America and Europe. Becker brings over 20 years of experience in medical device regulatory affairs with a strong track record in securing approvals for various cardiac devices. Gallagher, with 20 years in clinical research, has held leadership positions at major medical firms. The company also announces the transition of Vicki Bebeau from the Clinical and Regulatory team.

Neovasc announced the publication of a significant article on the efficacy of its heart device, the Neovasc Reducer™, in treating chronic refractory angina, in the International Journal of Cardiology. The RESOURCE study involved 658 patients across Europe, showing a procedural success rate of 96.7% with 39.7% of patients reporting significant relief in symptoms. The Reducer is CE-marked for this condition in Europe, providing a minimally invasive treatment option. Despite not being approved in the U.S., it holds FDA Breakthrough Device designation, highlighting its potential in addressing a critical health issue affecting up to 1.8 million Americans.

Neovasc Inc. (NVCN) has announced strategic initiatives aimed at enhancing shareholder value and extending its cash runway into 2024. The focus is on expanding reimbursement and revenue for the Neovasc Reducer™ in international markets, while the company is also pursuing FDA approval for the COSIRA II trial. Aimed at improving refractory angina treatment, this trial will involve approximately 380 patients. Additionally, Neovasc is seeking CE Mark approval for its Tiara TA mitral valve replacement system, but has paused the Tiara TF program to concentrate resources. Workforce reductions are expected to save over $20 million over the next two years.

Neovasc Inc. announces that its Neovasc Reducer® has received national reimbursement approval in England. This decision, part of the High-Cost Tariff Excluded Devices (HCTED) catalogue, enables NHS England to cover costs associated with the Reducer system, improving access for patients suffering from refractory angina. The CEO, Fred Colen, highlighted this move as a significant step toward broader market adoption while emphasizing the positive reception of Reducer therapy. The device is not yet available in the U.S. but has received FDA Breakthrough Device designation.

Neovasc Inc. (NVCN) announced results from its Annual General Meeting held on June 3, 2021, in Vancouver. Shareholders re-elected board members including Steven Rubin and Paul Geyer, with majority votes for each nominee exceeding 90%. The company also confirmed the approval of unallocated options under its stock option plan, with 90.49% of votes in favor, and re-appointed Grant Thornton LLP as auditors. Neovasc develops medical devices for cardiovascular treatments, including Reducer and Tiara, the latter currently under clinical investigation in multiple regions.

Neovasc Inc. (NASDAQ, TSX: NVCN) announced it has received a Notification Letter from Nasdaq, indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company did not meet this requirement for 30 consecutive business days leading up to May 21, 2021. Neovasc has 180 days, until November 22, 2021, to restore compliance by achieving a closing bid price of at least $1.00 for 10 consecutive business days. Despite this notification, the company's operations remain unaffected, and the letter does not impact its listing on the Toronto Stock Exchange.

Neovasc Inc. (NASDAQ, TSX: NVCN) announced that the Higher Regional Court in Munich upheld a prior judgment recognizing Edwards Lifesciences' co-entitlement rights to the Tiara™ European patent. This decision has no associated monetary awards. Neovasc is evaluating options for appeal. The company specializes in medical devices for cardiovascular treatment, including its Reducer and Tiara™ products, the latter currently in clinical trials. Neovasc has faced legal challenges regarding its patents, which could impact investor confidence.

Neovasc has announced its sponsorship of a symposium at EuroPCR 2021 to discuss long-term clinical data on the Reducer, which is designed for treating refractory angina. This event, occurring from May 18-20, 2021, will feature notable experts in cardiovascular treatments. Although the Reducer is CE-marked in Europe, it is not yet approved for commercial use in the U.S., though it has received FDA Breakthrough Device designation. The Reducer aims to address a significant unmet medical need affecting 600,000 to 1.8 million Americans with refractory angina.

Neovasc has enrolled the first patient in the COSIMA trial, aimed at treating refractory microvascular angina using the Neovasc Reducer. The trial, led by Prof. Tommaso Gori at University Hospital, Mainz, Germany, will involve up to 144 patients and assess the effectiveness of the Reducer compared to standard optimized medications. Microvascular angina affects millions, often leading to severe symptoms and hospitalizations. The Reducer device is already CE-marked in Europe and offers a minimally invasive solution for managing this condition.